| Popis: |
Biopharmaceuticals are most often administered to patients subcutaneously by way of a device delivery system, with these two components – biopharmaceutical and device – constituting the combination product. Combination products that employ different device components for the same drug or biologic and those that employ the same device component across different drugs and biologics necessitate a strong scientific comparability bridge be established. The science-based decision strategies follow a risk-based approach in the generation of needed bridging data and/or the leveraging of prior experience and knowledge for an established drug or device component. An impact analysis has proven a useful method in determining the “right study tool” is applied in generating sufficient comparability data to demonstrate bridging to the to-be-marketed combination product. The approaches and considerations described in this chapter are applicable to all phases of product life cycle: early-stage development, pivotal clinical studies, product launch, and post-approval change management. |
